Australian TGA registration advice and submission support

Who we support

For medical device and IVD manufacturers entering Australia, including businesses with overseas evidence or existing ARTG inclusions planning their next stage.

• First Australian entry: confirm pathway, applicant and preparation sequence
• Existing CE or FDA evidence: check scope and consistency with products intended for Australia
• Existing ARTG inclusion: discuss product changes, document updates and post-market coordination

Registration work grounded in your product

Entry pathways and documentation requirements vary by product. At the outset, confirm intended use, model scope, classification, the existing quality system and overseas regulatory evidence, then identify what must be prepared or supplemented.

• TGA pathway assessment and submission strategy
• Review of classification, technical documentation, labels and instructions for use
• ARTG application preparation, submission coordination, regulatory correspondence and supplementary information management
• Support for post-registration changes, adverse events and ongoing compliance

Defining scope after the initial discussion

Based on product and document status, agree stage questions, client inputs, deliverables, contacts and next steps. Confirm scope and fees again for additional models, evidence or other work.

• Pathway assessment: record classification rationale, proposed evidence pathway and matters to verify
• Document review: list files, gaps, owners and version requirements
• Submission coordination: define submission arrangements, regulatory communication and follow-up scope
• Ongoing maintenance: agree changes, compliance support and associated fees separately

Consider Sponsor and post-market arrangements together

Sonictec provides Australian Sponsor services, clarifying manufacturer, Sponsor and distributor responsibilities, documentation coordination and ongoing maintenance before engagement. Registration work must align with subsequent supply arrangements.

Prescribed List: assess applicability by product

The Prescribed List concerns private health insurance benefits for certain medical devices and human tissue products; it is not a universal reimbursement list. We support applicability assessment, application pathways and preparation. TGA registration and listing eligibility must be assessed separately.

• Initial product and listing eligibility assessment
• Reviewing clinical value and supporting evidence
• Application preparation and communication support

Estimating costs and timing

Provide use, model scope, certificates and evidence, ARTG status and supply timing. Separate service fees, official TGA costs, ongoing Sponsor services and potential testing or translation. Timing depends on documentation, pathway and review; no standard quote or approval promise is made before initial assessment.

Technical documentation preparation

Review product descriptions, labels, technical files, clinical or performance evidence and existing authorizations. Identify gaps against applicable requirements and coordinate supplements with the manufacturer.

Submission and regulatory communication

Progress the application once applicable prerequisites are met, tracking status and coordinating questions and supplementary information. TGA conducts the regulatory assessment and makes the decision; processing depends on the application.

Collaboration process and stage deliverables

1. Initial document discussion: provide intended use, model overview, certificates and Australian progress. Begin with an overview; exchange technical files as agreed.
2. Scope and quotation: define pathway assessment, document review or submission deliverables and itemise service fees, official costs and external work.
3. Project delivery: agree contacts, document versions and responsibility for supplements, following progress in stages; check Sponsor and documentation conditions before applying.
4. Ongoing coordination: coordinate regulatory questions, product changes and maintenance as agreed; confirm additional work separately.

View the initial consultation checklist 　Understand service fees versus official fees

Related submission cases

Explore product classes, project considerations and redacted certificates from submissions our team supported.

Frequently asked questions

Further reading

• Choosing a TGA service provider: scope, fees and ongoing responsibilities
• What is included in a TGA quote? Comparing service fees, official fees and annual charges
• How do TGA registration consulting and an Australian Sponsor differ?
• What should you prepare before a TGA registration consultation?
• What should be checked for TGA when CE or FDA documentation already exists?
• Australian UDI is being phased in: what should Chinese manufacturers check now?